Philippe Massiot Email & Phone Number

Paris, Fr

Saint-Ouen

Région De Boulogne-Billancourt, France

 - Management of study activities (phase I and III) conducted in different countries - Responsible for the accuracy of the data collected by the CRAs - Validation of clinical data - Collaboration in the amendments of the protocol and study related documents - Regulatory and administrative management - Follow up of budget - Pre-selection, initiation and monitoring visits on site - Investigational product management - CRF, eCRF, IWRS design and specifications - CRA training - Trial Master File management - Project meetings (Investigator meeting, CRA meeting, …) - Communication with subsidiaries, CROs, commercial partners - EMA inspection6-month mission (May to Dec. 2015) as a Project Manager in International Regulatory Affairs: - Management of Labeling (Product Information) documents (CCDS, CorePIL,…) - Improvement of the different processes related to the Reference Product Information

Avenue De La Cristallerie, Sévres

Key responsibilities: - Management of the set up, follow up and coordination of clinical research projects - Manager of multisite and international projects in various therapeutics area (in particular in cardiovascular and oncology therapeutics area) - Supervision of the execution of contracted services to fulfill to requirements from the sponsor - Responsible for the timelines - Supervision and participation in the creation of study specific documents - Coordination of the relationships with the various external participants to the project (Sponsor / CROs, investigators sites, experts...) - Participation in the external meetings related to the project (investigator meetings, bid-defence meetings) - Invoicing

Montsoult Maffliers

- Management of overall international clinical study management (phase I to IV) including set up and validation of clinical software database, trial monitoring and close out, participation in and presentations at investigator, monitor and client meetings. - Responsible for ensuring that design, implementation and timelines of study deliverables are consistent with client and budget expectations. - Major client contact for the allocated projects. Responsible for pro-active communication to client. - Communicate and coordinate timelines for the internal and external functional units.- Coordinate resources, priority and resolve conflicts.- Responsible for study team training by conducting regular team meetings and communication sessions and provide coaching to other members of the team

Montsoult Maffliers

- Responsible for supporting Project Leader in clinical study management including assisting in the preparation of specific trial documents and presentation documents.- Responsible for all project management activities related to site initiation. - Monitor site queries. Coordinate activities related to investigator site assets.- Communicate and coordinate timelines for the internal and external functional units.- Coordinate resources and resolve conflicts. Understand study budget with respect to their other study activities

Région De Seville, Espagne

- Development of a synthesis line (sol-gel)- Training and coaching of Trainees- Writing of scientific articles

Phd, Chemistry

Phd, Inorganic Chemistry

Phd, Inorganic Chemistry

Master Science, Inorganic Chemistry

Master Science, Inorganic Chemistry